FDA 510(k)

末梢CT画像システム

K番号: K252249 · 2026-03-13

決定日2026-03-13

製品コードJAK

諮問委員会RA

決定Substantially Equivalent

医療機器の概要

Extremity CT Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Mars Bioimaging , Ltd.. It received FDA 510(k) clearance on 2026-03-13 under 510(k) number K252249. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Extremity CT Imaging System?

Extremity CT Imaging System is a medical device that received FDA 510(k) clearance on 2026-03-13. The listed applicant is Mars Bioimaging , Ltd.. The 510(k) number is K252249.

When did Extremity CT Imaging System receive FDA 510(k) clearance?

Extremity CT Imaging System received FDA 510(k) clearance on 2026-03-13, under 510(k) number K252249.

Who is the listed applicant for Extremity CT Imaging System?

The FDA 510(k) record lists Mars Bioimaging , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Extremity CT Imaging System?

The FDA product code for Extremity CT Imaging System is JAK.

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末梢CT画像システム

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：JAK）

公式ソース